Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine

March 6, 2012 updated by: Nematollah Jonaidi Jafari
The purpose of this study is to determine whether short-term Atorvastatin can increase the immunity response to hepatitis B vaccination in vaccine Nonresponders.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

20 person of vaccinated individuals who have HBsAb<10 after 3 dose hepatitis B vaccination who called Nonresponders will be randomly allocated in 2 groups. one group receive short-term Atorvastatin and other group receive placebo.both group will be vaccinated with hepatitis B vaccine and then immunity response will be measured.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previous 3 dose hepatitis B vaccination
  • Negative HBc Ab
  • Negative HBs Ag
  • HBs Ab less than 10 in ELIZA

Exclusion Criteria:

  • positive serologic evidence of Hepatitis B infection
  • Chronic use of Atorvastatin
  • Immunosuppressive Disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Atorvastatin
will receive one 40 mg Atorvastatin tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeast-derived Hepatitis B vaccine intramuscular in left Deltoid muscle
Drug: Atorvastatin
one 40 mg Atorvastatin tablet orally per day for 10 days
Placebo Comparator: Placebo
will receive one Placebo tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeast-derived Hepatitis B vaccine intramuscular in left Deltoid muscle
Drug: placebo
one Placebo tablet orally per day for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in serum HBsAb level
Time Frame: 1 month after vaccination
HBsAb level in serum measurement with quantitative ELIZA method
1 month after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-4 level in WBC culture
Time Frame: 1 month after vaccination
IL-4 level measurement with polymerase chain reaction method
1 month after vaccination
IL 17 level in WBC culture
Time Frame: 1 month after vaccination
IL 17 level measurement with polymerase chain reaction method
1 month after vaccination
TGF-beta level in WBC culture
Time Frame: 1 month after vaccination
TGF-beta level measurement with polymerase chain reaction method
1 month after vaccination
IFN-gamma level in WBC culture
Time Frame: 1 month after vaccination
IFN-gamma level measurement with polymerase chain reaction method
1 month after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nematollah Jonaidi Jafari

Investigators

  • Study Chair: Nematollah Jonaidi Jafari, MD, Baqiyatallah University of Medical Sciencesc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Estimate)

March 8, 2012

Last Update Submitted That Met QC Criteria

March 6, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • behdasht-90-6-16
  • IRCT201109147556N1 (Registry Identifier: Iranian Registry of Clinical Trials)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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